580CD Display Driver
FDA 510(k) K926162 · Vidco, Inc.
510(k) numberK926162
Submission
- Device name
- 580CD Display Driver
- Applicant
- Vidco, Inc.
Beaverton, OR, US - Received
- December 8, 1992
- Decision date
- November 8, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXJ – Display, Cathode-Ray Tube, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2450
- Specialty
- Cardiovascular
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| K170460 | Sorin ConnectDXJ · Special | Sorin Group Deutschland GmbH | 06/08/2017SE |
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More from Barco N.V.
| 510(k) | Device | Decision |
|---|---|---|
| K972880 | MDP2000 Medical Data ProcessorMSX · Traditional | 10/22/1997SE |
| K934093 | 580CDR Display DriverDXJ · Traditional | 08/18/1994SE |
| K932894 | 620CSR Display DriverDXJ · Traditional | 06/20/1994SE |
| K926298 | 520 Display Driver- Status IDRT · Traditional | 05/04/1994SE |
| K926219 | 516YT Display DriverDXJ · Traditional | 12/16/1993SE |
| K890353 | SMDS460 Surgical Monitor Display SystemDXJ · Traditional | 03/02/1989SE |
Questions and answers
When was 580CD Display Driver cleared by the FDA?
580CD Display Driver (K926162) received a 510(k) decision of Substantially Equivalent on November 8, 1993, 335 days after the submission was received.
What is the product code of K926162?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.